← Product Code [ILO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO) · K950395

# THERMOCOOL SYSTEM (K950395)

_Zimmer, Inc. · ILO · Aug 18, 1995 · Physical Medicine · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K950395

## Device Facts

- **Applicant:** Zimmer, Inc.
- **Product Code:** [ILO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO.md)
- **Decision Date:** Aug 18, 1995
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5720
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K950395](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K950395)

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